This is a prospective, randomized controlled study to compare the efficacy of the Gyrus ACMI PlasmaKnife™ electrosurgical device used with the Gyrus ACMI Workstation versus monopolar electrosurgical device (i.e. Bovie®) for tonsillectomy.

The primary outcome will study the potential for reduced post-operative pain when the PlasmaKnife is used for tonsillectomy compared to a monopolar device. Secondary outcomes such as return to normal diet and activity as well as a range of complications including primary and secondary bleeding will be included in the study.

The study will involve approximately 100 patients at Children’s Hospital of Michigan that meet the criteria for tonsillectomy (with or without adenoidectomy) for infected tonsils or airway obstruction.

The study will be documented through the use of Case Report Forms.

Eligibility

Ages Eligible for Study:

4 Years to 16 Years

Genders Eligible for Study:

Both

Criteria

Inclusion Criteria:

Patient should be between the ages of 4 and 16 years old inclusive.

Patient should meet criteria for tonsillectomy.

Patient’s guardian able and willing to complete patient diary and keep to the follow-up visit.

Guardian able to understand English (written and oral).

Exclusion Criteria:

Patient that has active medical implant(s) such as pacemaker, cochlear implant, etc.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466544